453 Regulatory Submissions Jobs

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

As an Experienced Study Start up Submissions Coordinator at Medpace, you will play a crucial role in the activation of investigative sites in all phases of clinical trials. Your responsibilities will include preparing, reviewing, and submitting documents to Regulatory Agencies, communicating with global study teams, identifying risks to site activations, providing guidance in ethics and regulatory submissions, and ensuring compliance with regulations. You will also be the main contact for Ethical and Regulatory submission-related activities, liaising with investigative sites, advising sponsors on changing regulations, and tracking submissions for timely filing. **Key Responsibilities:** - Pe...

Role & responsibilities: To support and manage regulatory submissions, product registrations, and lifecycle maintenance activities in compliance with global regulatory requirements, ensuring timely approvals and sustained market authorization of pharmaceutical and life science products. Key Responsibilities Prepare, review, and submit regulatory dossiers (CTD / eCTD) for regulated and semi-regulated markets Handle product registrations, renewals, variations, and amendments Compile and maintain CTD Modules 15 as per regulatory guidelines Respond to regulatory authority queries, deficiency letters, and commitments within defined timelines Coordinate with QA, QC, R&D, Production, Packaging, and...

Key Responsibilities 1. Dossier Preparation & Submission Prepare, compile, review, and submit EU CTD/eCTD dossiers (Modules 15) for pharmaceutical finished formulations. Ensure accuracy, completeness, and compliance of dossiers as per EU guidelines (EMA/ICH). Coordinate with internal teams (R&D, QA, QC, F&D, Packaging) for timely collection of data required for dossier compilation. 2. Regulatory Strategy & Planning Develop regulatory strategies for new product development for EU markets. Assess regulatory requirements for new molecules, new dosage forms, and technology transfers. Provide regulatory inputs during product development and scale-up stages. 3. Variations & Post-Approval Activitie...

As a LEORA Analyst within the CTPO - LEORA team at JPMorgan Chase, your role involves supporting Supplier Risk Reporting and Inventory submission, crucial for effective Outsourcing Governance and regulatory compliance. You will report functionally to the LEORA lead based in Hyderabad and collaborate closely with stakeholders across the EMEA and APAC regions. **Key Responsibilities:** - Ensure the integrity and timeliness of data for successful regulatory submissions. - Perform inventory reconciliations with source systems to maintain data accuracy and integrity. - Collaborate with cross-functional teams to ensure timely updates in the LEORA portal for relevant data points. - Support technica...

Manage and oversee the preparation and submission of regulatory documents to health authorities. Coordinate with cross-functional teams to ensure timely and accurate submission of documents. Develop and implement effective submission strategies to meet business objectives. Collaborate with internal stakeholders to gather information and support for submissions. Review and edit submission documents for accuracy, completeness, and compliance. Ensure compliance with global regulatory practices and submission guidelines. Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to ver...

As a Junior Regulatory Affairs Executive, you will have the opportunity to work with a dynamic team of professionals in the field of regulatory affairs. Key Responsibilities: - Conducting technical writing tasks to prepare necessary documentation for regulatory submissions - Collaborating with manufacturers of medical and diagnostic devices in product design, developing specifications and testing - Utilizing problem-solving skills to address regulatory compliance issues and ensure product safety - Troubleshooting potential regulatory challenges and implementing effective solutions - Assisting in the coordination of regulatory submissions and approvals with relevant authorities - Staying up-t...

Sending accurate quotation with in same day or next day and Regulatory Affairs documents to the customers within a week time. Timely follow up by email and call with the customers on the quotation & samples. Collaborate with the Sales Team for new business/inquiry generation. Special attention on AVD projects & fulfilling Make calls for sample & quote follow up. Handling Technical queries or any issues promptly & effectively. Timely resolve customers complaints / requests. Efficiently process sample request for the clients with the help of sales team. Ensure 100% of sample transactions are documented correctly in the system and generate monthly reports for analysis. New product promotions. E...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Senior Regulatory Affairs Associate Good experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant ...

Department - Regulatory Affairs (Formulation) Role & responsibilities - Preparation of successful pharmaceutical license application to Global Regulatory agencies. Reviewing regulatory documents such as manufacturing batch records, packaging batch records, analytical method, validation protocol and reports, stability protocol and record cards. Responsible for co-coordinating with cross-departmental teams such as Contract Lab and Contract Manufacturer for timely submission if required, collection of documents, review of documents and resolving any regulatory discrepancies. Responsible for compiling regulatory documents including Quality Module of Dossier for Global market as per regional requ...

Role Overview: As the Director of Real World Statistics, you will focus on applying advanced statistical methodologies to support a rare disease portfolio, with a strong emphasis on disease registry initiatives and regulatory submissions. This role sits within a dedicated Real World Evidence (RWE) capability that combines deep statistical expertise with extensive experience in regulatory applications. We are seeking a curious, driven, and detail-oriented leader with proven experience in disease registries and longitudinal observational cohorts. You will provide statistical leadership, mentor junior statisticians, and deliver high-quality analyses aligned with regulatory standards. Key Respon...

Prepare, review, and maintain regulatory documentation. Prepare dossiers. Assist in filing applications, registrations, renewals. Freshers & experienced can also apply.

Job Overview Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues. Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables. Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables. Contribute to scientific publi...

Tracks, collects, and reviews all components for submission to Health Authorities. Performs submission publishing activities and interacts with responsible parties for quality submission documents. Facilitates submission team meetings and supports the submission process. Prepares Cover Letter, FDA Forms, and submission content plan for Investigational, Marketed Applications submissions. Attends Submission Team and kick off meetings, represents RISM, and drives submission publishing timelines. Coordinates Initial IND Kick off meeting submissions and develops/updates job aid documents for departmental processes. Job Requirements 2-4 years of relevant experience in regulatory submissions. Found...

As the Upstream Manufacturing Documentation at Syngene, your role involves leading the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. Your expert leadership is crucial for overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics. You will also be responsible for technology transfer to support scale-up and GMP manufacturing, building strong relationships with CMOs to optimize efficiency, productivity, quality, and supply assurance. Key Responsibilities: - Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and...

As a Senior Manager in Regulatory Affairs at our company, your role will involve the following responsibilities: - Act as a regulatory lead and take charge of all regulatory affairs projects - Execute and ensure timely delivery of all regulatory affairs projects - Assist in drafting and compiling dossiers for submission in various markets - Conduct quality checks on all outputs from the regulatory affairs team - Manage and oversee all regulatory submissions made by the team - Communicate project status updates to clients and the Head of Regulatory Affairs - Provide mentorship to less experienced or new team members Qualifications Required: - You should have a total of 10 to 15 years of regul...

As a Regulatory Medical Writer-Clinical trials (RMW-CT), you will be responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) as designated by leadership. Your role will involve supporting the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests using available reference materials. You may lead interactions with sponsors or designated HAs, contributing to the preparation of submission materials, and ensuring the accuracy and quality of submission-ready documents. Additionally, you will partner with sponsor/HAs leadership to prepare high-quality, accur...

As a Clinical Safety and/or PSS Operations Assistant at Fortrea, your role will involve assisting with the overall Clinical Safety and/or PSS operations associated with products, including managing the entire adverse events process. Your responsibilities will include: - Performing case intake and triage of incoming safety information or reports from various sources - Data entry of safety data onto adverse event tracking systems - Writing patient narratives and accurately coding adverse events using MedDRA - Assisting in the listedness assessment against appropriate label - Generating queries and collecting missing or discrepant information in consultation with medical staff - Submitting expe...

Job Description Required Qualifications: Licensed clinician (RN, PharmD, MD, NP, PA, or equivalent) with 10+ years of clinical experience. Minimum 10+ years experience in product management, clinical informatics, or usability/human factors engineering within healthcare technology or medical devices. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). Strong understanding of clinical risk, safety analysis, and usability validation methodologies. Proven ability to translate complex clinical workflows into clear design and engineering requirements. Excellent cross-functional communication and documentation skills. Preferred: Experience sup...

As an experienced medical writer, your role will involve writing high-quality CTD modules including nonclinical and clinical overviews & summaries such as Module 2.5, 2.4, 2.7 as per the EU submission requirements. You will also be responsible for responding to clinical deficiencies, assisting in drug development strategy, updating SmPC, Patient information leaflet, CCDS, Safety variations, preparing clinical study reports, study design, and synopsis. Additionally, you will play a key role in the clinical development strategy, review of study reports, published papers, literature search, and regulatory evaluation. Your expertise will be crucial in Rx to OTC evaluation, PSURs, PADER, and RMP....

Mosaic Wellness is building digital first, health brands for elective health concerns. Man Matters , is a digital elective health platform for men, helping 2.5M men every year diagnose and solve for their hair loss, beard growth, fitness and nutrition concerns by offering personalized treatment plans and access to expert doctors and health coaches. Be Body Wise , is an online womens elective health platform, serving 4M women every year by providing personalized solutions and doctor consults across concerns for hair health, body care, Sleep and nutrition. Little Joys , is an online health platform for kids, helping 2M parents every year solve for their childs physical, mental and emotional de...

Job Description: We are looking for a Regulatory Affairs Associate with 4 to 10 years of experience in managing CMC aspects, dossier compilation, and submission for US, EU, and Brazil markets. This role will focus on leading the preparation of high-quality regulatory submissions and managing complex CMC documentation for various dosage forms, including solid or injectable products. Key Responsibilities: Independently compile and review submission dossiers in CTD/eCTD format for regulatory authorities like US FDA, EMA, and ANVISA. Review CMC documentation for regulatory compliance, strategize filing categories, and ensure submissions are completed within deadlines. Conduct due diligence for n...

Note : F2F second round Bangalore-based candidates preferred. Description: As a Senior Consultant, for regulatory operations, you will have responsibility to collaborate, manage and deliver on regulatory programs. You will be the subject matter expert in regulatory information and content migration working with a delivery team that spans both business and technical areas. You will need to ensure the regulatory data are identified and categorized correctly and moved to the proper application. You will oversee client deliverables to ensure they meet customer expectations and compliance regulations. You will be responsible for collaborating across the delivery team, including program managers a...

As a Regulatory Affairs Manager, you will play a crucial role in developing and implementing global regulatory strategies to secure product approvals and market access in various regions such as FDA, EMA, MHRA, TGA, and Health Canada. Your responsibilities will include: - Serving as a CMC expert in managing Initial Submissions and Life cycle management activities for Global Regulatory across multiple markets and dosage forms including OSDs, Ophthalmic, Complex Injectable, and Liposomal Dosage forms. - Authoring high-quality CMC documentation such as Dossiers and Deficiency responses, ensuring technical congruency and regulatory compliance. - Leading cross-functional teams for new product dev...

Role Overview: As a Medical Writer at our company, you will play a crucial role in creating high-quality documents for various medical and scientific projects. Your expertise in scientific writing and in-depth knowledge of medical and healthcare concepts will contribute to the success of clinical trials, regulatory submissions, publications, and other scientific materials. You will collaborate closely with cross-functional teams to ensure the accuracy and compliance of all written documents. Key Responsibilities: - Write and edit various medical and scientific documents such as clinical study reports, regulatory submissions, and research papers. - Ensure that all documents adhere to regulato...